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Author: R. D. McDowall
Publisher: Royal Society of Chemistry
ISBN: 178801281X
Category : Computers
Languages : en
Pages : 660
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Book Description
This book provides practical and detailed advice on how to implement data governance and data integrity for regulated analytical laboratories working in the pharmaceutical and allied industries.
Author: R. D. McDowall
Publisher: Royal Society of Chemistry
ISBN: 178801281X
Category : Computers
Languages : en
Pages : 660
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Book Description
This book provides practical and detailed advice on how to implement data governance and data integrity for regulated analytical laboratories working in the pharmaceutical and allied industries.
Author: Santhosh Kumar Balan
Publisher: BoD – Books on Demand
ISBN: 1839687983
Category : Computers
Languages : en
Pages : 154
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Book Description
Data integrity is the quality, reliability, trustworthiness, and completeness of a data set, providing accuracy, consistency, and context. Data quality refers to the state of qualitative or quantitative pieces of information. Over five sections, this book discusses data integrity and data quality as well as their applications in various fields.
Author: Niall Richard Murphy
Publisher: "O'Reilly Media, Inc."
ISBN: 1491951176
Category :
Languages : en
Pages : 552
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Book Description
The overwhelming majority of a software system’s lifespan is spent in use, not in design or implementation. So, why does conventional wisdom insist that software engineers focus primarily on the design and development of large-scale computing systems? In this collection of essays and articles, key members of Google’s Site Reliability Team explain how and why their commitment to the entire lifecycle has enabled the company to successfully build, deploy, monitor, and maintain some of the largest software systems in the world. You’ll learn the principles and practices that enable Google engineers to make systems more scalable, reliable, and efficient—lessons directly applicable to your organization. This book is divided into four sections: Introduction—Learn what site reliability engineering is and why it differs from conventional IT industry practices Principles—Examine the patterns, behaviors, and areas of concern that influence the work of a site reliability engineer (SRE) Practices—Understand the theory and practice of an SRE’s day-to-day work: building and operating large distributed computing systems Management—Explore Google's best practices for training, communication, and meetings that your organization can use
Author: José Rodríguez-Pérez
Publisher: Quality Press
ISBN: 0873899873
Category : Business & Economics
Languages : en
Pages : 137
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Book Description
Data integrity is a global mandatory requirement for the regulated healthcare industry. It is more than a mere expectationits a basic element of good documentation practices, one of the most fundamental pillars of a quality management system. Robustness and accuracy of the data submitted by manufacturers to regulatory authorities when bringing a medical product to market are crucial. The purpose of this book is to consolidate existing data integrity principles and expectations from several regulatory sourcesincluding the U.S. Food and Drug Administration, World Health Organization, and European Medicines Agencyinto a single and handy document that provides detailed, illustrative implementation guidance. It serves as a means of understanding regulatory agencies position on good data management and the minimum expectation for how medical product manufacturers can achieve compliance.
Author: Danette McGilvray
Publisher: Academic Press
ISBN: 0128180161
Category : Computers
Languages : en
Pages : 378
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Book Description
Executing Data Quality Projects, Second Edition presents a structured yet flexible approach for creating, improving, sustaining and managing the quality of data and information within any organization. Studies show that data quality problems are costing businesses billions of dollars each year, with poor data linked to waste and inefficiency, damaged credibility among customers and suppliers, and an organizational inability to make sound decisions. Help is here! This book describes a proven Ten Step approach that combines a conceptual framework for understanding information quality with techniques, tools, and instructions for practically putting the approach to work – with the end result of high-quality trusted data and information, so critical to today's data-dependent organizations. The Ten Steps approach applies to all types of data and all types of organizations – for-profit in any industry, non-profit, government, education, healthcare, science, research, and medicine. This book includes numerous templates, detailed examples, and practical advice for executing every step. At the same time, readers are advised on how to select relevant steps and apply them in different ways to best address the many situations they will face. The layout allows for quick reference with an easy-to-use format highlighting key concepts and definitions, important checkpoints, communication activities, best practices, and warnings. The experience of actual clients and users of the Ten Steps provide real examples of outputs for the steps plus highlighted, sidebar case studies called Ten Steps in Action. This book uses projects as the vehicle for data quality work and the word broadly to include: 1) focused data quality improvement projects, such as improving data used in supply chain management, 2) data quality activities in other projects such as building new applications and migrating data from legacy systems, integrating data because of mergers and acquisitions, or untangling data due to organizational breakups, and 3) ad hoc use of data quality steps, techniques, or activities in the course of daily work. The Ten Steps approach can also be used to enrich an organization's standard SDLC (whether sequential or Agile) and it complements general improvement methodologies such as six sigma or lean. No two data quality projects are the same but the flexible nature of the Ten Steps means the methodology can be applied to all. The new Second Edition highlights topics such as artificial intelligence and machine learning, Internet of Things, security and privacy, analytics, legal and regulatory requirements, data science, big data, data lakes, and cloud computing, among others, to show their dependence on data and information and why data quality is more relevant and critical now than ever before. - Includes concrete instructions, numerous templates, and practical advice for executing every step of The Ten Steps approach - Contains real examples from around the world, gleaned from the author's consulting practice and from those who implemented based on her training courses and the earlier edition of the book - Allows for quick reference with an easy-to-use format highlighting key concepts and definitions, important checkpoints, communication activities, and best practices - A companion Web site includes links to numerous data quality resources, including many of the templates featured in the text, quick summaries of key ideas from the Ten Steps methodology, and other tools and information that are available online
Author: Laura Sebastian-Coleman
Publisher: Newnes
ISBN: 0123977541
Category : Computers
Languages : en
Pages : 404
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Book Description
The Data Quality Assessment Framework shows you how to measure and monitor data quality, ensuring quality over time. You'll start with general concepts of measurement and work your way through a detailed framework of more than three dozen measurement types related to five objective dimensions of quality: completeness, timeliness, consistency, validity, and integrity. Ongoing measurement, rather than one time activities will help your organization reach a new level of data quality. This plain-language approach to measuring data can be understood by both business and IT and provides practical guidance on how to apply the DQAF within any organization enabling you to prioritize measurements and effectively report on results. Strategies for using data measurement to govern and improve the quality of data and guidelines for applying the framework within a data asset are included. You'll come away able to prioritize which measurement types to implement, knowing where to place them in a data flow and how frequently to measure. Common conceptual models for defining and storing of data quality results for purposes of trend analysis are also included as well as generic business requirements for ongoing measuring and monitoring including calculations and comparisons that make the measurements meaningful and help understand trends and detect anomalies. - Demonstrates how to leverage a technology independent data quality measurement framework for your specific business priorities and data quality challenges - Enables discussions between business and IT with a non-technical vocabulary for data quality measurement - Describes how to measure data quality on an ongoing basis with generic measurement types that can be applied to any situation
Author: Robert S. DiStefano
Publisher:
ISBN: 9780831134228
Category : Business & Economics
Languages : en
Pages : 0
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Book Description
Asset data integrity is a critical aspect of every business, yet it is often overlooked. This book will not only provide an appreciation of this fact, it will also provide a road map to achieving value out of something most CEOs, managers, and workers often overlook. The authors bring many years of experience and hands-on expertise that cannot be obtained elsewhere. An assessment tool is provided so once the problem is recognized by the reader, areas of improvement can be easily recognized. A detailed appendix provides further clarity.
Author: Robert McDowall
Publisher: Royal Society of Chemistry
ISBN: 1782624074
Category : Science
Languages : en
Pages : 778
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Book Description
Guiding chromatographers working in regulated industries and helping them to validate their chromatography data systems to meet data integrity, business and regulatory needs. This book is a detailed look at the life cycle and documented evidence required to ensure a system is fit for purpose throughout the lifecycle. Initially providing the regulatory, data integrity and system life cycle requirements for computerised system validation, the book then develops into a guide on planning, specifying, managing risk, configuring and testing a chromatography data system before release. This is followed by operational aspects such as training, integration and IT support and finally retirement. All areas are discussed in detail with case studies and practical examples provided as appropriate. The book has been carefully written and is right up to date including recently released FDA data integrity guidance. It provides detailed guidance on good practice and expands on the first edition making it an invaluable addition to a chromatographer’s book shelf.
Author: Orlando López
Publisher:
ISBN: 9781032339887
Category :
Languages : en
Pages : 0
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Book Description
Data integrity is fundamental in a pharmaceutical and medical devices quality system. This book provides practical information to enable compliance with data integrity, while highlighting and efficiently integrating worldwide regulation into the subject. The ideas presented in this book are based on many years' experience in regulated industries in various computer systems development, maintenance, and quality functions. In addition to case studies, a practical approach will be presented to increase efficiency and to ensure that the design and testing of the data integrity controls are correctly achieved.
Author: Shazia Sadiq
Publisher: Springer Science & Business Media
ISBN: 3642362575
Category : Computers
Languages : en
Pages : 440
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Book Description
The issue of data quality is as old as data itself. However, the proliferation of diverse, large-scale and often publically available data on the Web has increased the risk of poor data quality and misleading data interpretations. On the other hand, data is now exposed at a much more strategic level e.g. through business intelligence systems, increasing manifold the stakes involved for individuals, corporations as well as government agencies. There, the lack of knowledge about data accuracy, currency or completeness can have erroneous and even catastrophic results. With these changes, traditional approaches to data management in general, and data quality control specifically, are challenged. There is an evident need to incorporate data quality considerations into the whole data cycle, encompassing managerial/governance as well as technical aspects. Data quality experts from research and industry agree that a unified framework for data quality management should bring together organizational, architectural and computational approaches. Accordingly, Sadiq structured this handbook in four parts: Part I is on organizational solutions, i.e. the development of data quality objectives for the organization, and the development of strategies to establish roles, processes, policies, and standards required to manage and ensure data quality. Part II, on architectural solutions, covers the technology landscape required to deploy developed data quality management processes, standards and policies. Part III, on computational solutions, presents effective and efficient tools and techniques related to record linkage, lineage and provenance, data uncertainty, and advanced integrity constraints. Finally, Part IV is devoted to case studies of successful data quality initiatives that highlight the various aspects of data quality in action. The individual chapters present both an overview of the respective topic in terms of historical research and/or practice and state of the art, as well as specific techniques, methodologies and frameworks developed by the individual contributors. Researchers and students of computer science, information systems, or business management as well as data professionals and practitioners will benefit most from this handbook by not only focusing on the various sections relevant to their research area or particular practical work, but by also studying chapters that they may initially consider not to be directly relevant to them, as there they will learn about new perspectives and approaches.
